Linked Life Data

14999733

Source:http://linkedlifedata.com/resource/pubmed/id/14999733

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pubmed-article:14999733pubmed:abstractTextInjectable formulations of L-adrenaline are commonly used in emergency medicine. Despite numerous studies, the comparative contribution and kinetics of the L-adrenaline inactivation pathways during storage have not been conclusively evaluated. We examined the kinetics of L-adrenaline degradation in a prospective study and determined the extent of drug inactivation by different pathways during and beyond the stipulated product shelf-life in 42 batches of adrenaline ampules stored under controlled conditions. The content of L-adrenaline and degradation products was determined with a chiral high-performance liquid chromatography (HPLC) assay, and the degradation products were identified by mass spectrometric detection as D-adrenaline and L- and D-adrenaline sulfonate. The kinetics of the content change with storage was analyzed simultaneously for L-adrenaline and the degradation products using kinetic modeling. The lower acceptable level of adrenaline content in the formulation stated by US Pharmacopoeia (90% as a sum of L- and D-isomers) was attained after 2.0 years of storage, at which time the content of the therapeutically active L-isomer amounted to as low as 85%. The modeling revealed significant differences in the degradation kinetics in the formulations produced before and after 1997, whose cause remained unidentified in this study.lld:pubmed
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pubmed-article:14999733pubmed:authorpubmed-author:StepenskyDavi...lld:pubmed
pubmed-article:14999733pubmed:authorpubmed-author:ChornyMichael...lld:pubmed
pubmed-article:14999733pubmed:authorpubmed-author:SchumacherIla...lld:pubmed
pubmed-article:14999733pubmed:authorpubmed-author:DabourZiadZlld:pubmed
pubmed-article:14999733pubmed:copyrightInfoCopyright 2004 Wiley-Liss, Inc. and the American Pharmacists Association.lld:pubmed
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pubmed-article:14999733pubmed:volume93lld:pubmed
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pubmed-article:14999733pubmed:pagination969-80lld:pubmed
pubmed-article:14999733pubmed:dateRevised2006-11-15lld:pubmed
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pubmed-article:14999733pubmed:year2004lld:pubmed
pubmed-article:14999733pubmed:articleTitleLong-term stability study of L-adrenaline injections: Kinetics of sulfonation and racemization pathways of drug degradation.lld:pubmed
pubmed-article:14999733pubmed:affiliationResearch & Quality Control Laboratory, The Medical Corps, Mil. P.O. Box 02149, Israel Defense Forces, Israel Defense Forces, Israel.lld:pubmed
pubmed-article:14999733pubmed:publicationTypeJournal Articlelld:pubmed